CardioFocus launches HeartLight in U.S.

CardioFocus said yesterday it launched its HeartLight endoscopic ablation system in the U.S., touting that the 1st commercial procedure with the device had been performed at New York City’s Mount Sinai Hospital.

The HeartLight system allows electrophysiologists to control the delivery of laser energy through direct visual guidance to isolate pulmonary veins with a high procedural flexibility, a company spokesperson wrote to MassDevice.com. The device includes a compliant balloon to accommodate diverse PV anatomies and has a short learning curve to allow for quick adoption of the tech.

“More than 2.7 million people in the United States alone suffer from AF, and despite treatment advancements, the numbers are growing, mostly due to an aging population. Treating paroxysmal AF before it advances to a persistent or permanent state will drastically improve patient long-term outcomes. The HeartLight system offers a new approach to effective patient treatment through direct visualization, titratable energy and a compliant balloon design, all of which lead to durable pulmonary vein isolation with unprecedented access and control,” trial clinical investigator Dr. Srinivas Dukkipati of Mount Sinai Hospital said in a prepared statement.

Dr. Dukkipati led the 1st commercial procedure using the HeartLight and was lead author in a pivotal study of the device published in the Journal of The American College of Cardiology, with support from Dr. Vivek Reddy.

“HeartLight differs from other AF ablation solutions by allowing electrophysiologists to see within the heart and for the first time, visually direct the application of therapeutic laser energy. The system also allows for procedural flexibility through a highly compliant balloon that easily accommodates diverse anatomies. We are excited to offer the technology, following PMA approval based on our pivotal U.S. study that showed the majority of patients experienced freedom from paroxysmal AF at 12 months following a single ablation procedure. Both Dr. Dukkipati and Dr. Reddy have been instrumental in evaluating the HeartLight system so it is fitting that Mount Sinai is the first U.S. commercial HeartLight center. We are also pleased to see that many of the other pivotal study sites are interested in transitioning from clinical to commercial use of the system,” COO Burke Barrett said in a press release.

The company won FDA premarket approval for its HeartLight endoscopic ablation system in April, with indications for treating drug refractory recurrent symptomatic paroxysmal AF.

The approval was based on data from a 353-patient, multi-center pivotal clinical study which met the primary safety and efficacy endpoints and reported freedom from paroxysmal AF at 12 months post-procedure, the Marlborough, Mass.-based company said.

“Following approval from the U.S. FDA, we are pleased to now commercially offer HeartLight for paroxysmal AF patients in the U.S. market. HeartLight has already been used to treat more than 3,700 patients worldwide, and building on the first commercial U.S. procedure at Mount Sinai, we will continue to scale up installations at electrophysiology labs across the country to treat patients in need. Our focused and selective launch, which enables us to move forward strategically and work closely with hand-picked physicians and sites, is proceeding as planned. We continue to receive excellent feedback from interested physicians,” exec chair Paul LaViolette said in prepared remarks.